Microbiological Test Data—Assuring Data Integrity

Reference

1. 1.↵
   1. Sandle T.,
   2. Tidswell E. C.

   1. Tidswell E. C.

   Bioburden Control. In Aseptic Processing: Control, Compliance and Future Trends, Sandle T., Tidswell E. C., Eds.; DHI Publishing: Arlington Heights, IL, 2017; pp 163–192.
2. 2.↵
   1. Sutton S.

   The Limitations of CFU: Compliance to cGMP Requires Good Science. Journal of GXP Compliance 2012, 16 (1), 74–80.

   OpenUrl
3. 3.↵
   1. Sutton S.

   Accuracy of Plate Counts. Journal Valid. Technol. 2011, 17 (3), 42–46.

   OpenUrl
4. 4.↵
   1. Singer D.,
   2. Sutton S.

   Microbiological Best Laboratory Practices, USP <1117> Value and Recent Changes to a Guidance of Quality Laboratory Practices. Am. Pharm. Rev. 2011, 14 (4), 41–47.

   OpenUrl
5. 5.↵
   1. Sutton S.

   Limiting Avoidable Microbiological Variability. J. Valid. Technol. 2010, 16 (1), 50–56.

   OpenUrl
6. 6.↵
   1. Jarvis B.

   Statistical Aspects of the Microbiological Examination of Foods; Elsevier Scientific Publishers B.V.: Amsterdam, 1989.
7. 7.↵
   1. Saghee M. R.,
   2. Sandle T.,
   3. Tidswell E. C.

   1. Tidswell E. C.

   Sterility. In Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, Saghee M. R., Sandle T., Tidswell E. C., Eds.; Palmleaf Books Ltd.: London, 2010.
8. 8.↵
   1. Sandle T.,
   2. Tidswell E. C.

   1. Tidswell E. C.,
   2. Bennett S. E.

   Sterility. In Aseptic Processing: Control, Compliance and Future Trends, Sandle T., Tidswell E. C., Eds.; DHI Publishing: Arlington Heights, IL, 2017; pp 17–50.
9. 9.↵
   1. Smith R.,
   2. Von Tress M.,
   3. Tubb C.,
   4. Vanhaecke E.

   Evaluation of the ScanRDI as a Rapid Alternative to the Pharmacopoeial Sterility Test Method: Comparison of the Limits of Detection. Pda J. Pharm. Sci. Technol. 2010, 64 (4), 356–363.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Moldenhauer J.

    1. Sutton S.

    The Sterility Tests. In Rapid Sterility Testing, Moldenhauer J., Ed.; PDA/DHI Publishing: Arlington Heights, IL, 2011; pp 7–28.
11. 11.↵
    1. Vartoukian S. R.,
    2. Palmer R. M.,
    3. Wade W. G.

    Strategies for Culture of ‘Unculturable’ Bacteria. FEMS Microbiol. Lett. 2010, 309 (1), 1–7.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    1. Norris J. R.,
    2. Ribbons D. W.

    1. Postgate J. R.

    Viable Counts and Viability. In Methods in Microbiology, Norris J. R., Ribbons D. W., Eds.; Academic Press: New York, 1969.
13. 13.↵
    1. Barer M. R.,
    2. Harwood C. R.

    Bacterial Viability and Culturability. Adv. Microb. Physiol. 1999, 41 (February), 93–137.

    OpenUrlCrossRefPubMedWeb of Science
14. 14.↵
    1. Kell D. B.,
    2. Kaprelyants A. S.,
    3. Weichert D. H.,
    4. Harwood C. R.,
    5. Barer M. R.

    Viability and Activity in Readily Culturable Bacteria: A Review and Discussion of the Practical Issues. Antonie van Leeuwenhoek 1998, 73 (2), 169–187.

    OpenUrlCrossRefPubMedWeb of Science
15. 15.↵
    1. Kell D. B.,
    2. Young M.

    Bacterial Dormancy and Culturability: The Role of Autocrine Growth Factors. Cur. Opin. Microbiol. 2000, 3 (3), 238–243.

    OpenUrlCrossRefPubMedWeb of Science
16. 16.↵
    1. Odlaug T. O.,
    2. Ocwieja D. A.,
    3. Purohit K. S.,
    4. Riley R. M.,
    5. Young W. E.

    Sterility Assurance for Terminally Sterilized Products without End Product Sterility Testing. PDA J. Pharm. Sci. Technol. 1984, 38 (4), 141–147.

    OpenUrlAbstract/FREE Full Text
17. 17.↵
    1. Brown M. R. W.,
    2. Gilbert P.

    Increasing the Probability of Sterility of Medicinal Products. J. Pharm. Pharmacol. 1977, 29 (9), 484–491.

    OpenUrl
18. 18.↵
    1. Téllez S.,
    2. Casimiro R.,
    3. Vela A. I.,
    4. Fernández-Garayzábal J. F.,
    5. Ezquerra R.,
    6. Latre M. V.,
    7. Briones V.,
    8. Goyache J.,
    9. Bullido R.,
    10. Arboix M.,
    11. Domínguez L.

    Unexpected Inefficiency of the European Pharmacopoeia Sterility Test for Detecting Contamination in Clostridial Vaccines. Vaccine 2006, 24 (10), 1710–1715.

    OpenUrlPubMed
19. 19.↵
    FDA Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. U.S. Department of Health and Human Services: Silver Spring, MD, 2004.
20. 20.↵
    1. van Doorne H.,
    2. van Kampen B. J.,
    3. van der Lee R. W.,
    4. Rummenie L.,
    5. van der Veen A. J.,
    6. de Vries W. J.

    Industrial Manufacture of Parenteral Products in The Netherlands. A Survey of Eight Years of Media Fills and Sterility Testing. PDA J. Pharm. Sci. and Technol. 1998, 52 (4), 159–164.

    OpenUrl
21. 21.↵
    1. Stevens-Riley M.

    Parametric Release: A Regulatory Perspective. Am. Pharm. Rev. 2015, 18 (3).
22. 22.↵
    1. Sandle T.

    Assessing Process Hold Times for Microbial Risks: Bioburden and Endotoxin. Journal of GXP Compliance 2015, 19 (3), 1–9.

    OpenUrl
23. 23.↵
    1. Sandle T.,
    2. Skinner K.,
    3. Yeandle E.

    Optimal conditions for the recovery of bioburden from pharmaceutical processes: a case study. Eur. J. Parenteral Pharmaceut. Sci. 2013, 18 (3), 84–90.

    OpenUrl
24. 24.↵
    1. Nyström T.

    Not Quite Dead Enough: On Bacterial Life, Culturability, Senescence, and Death. Arch. Microbiol. 2001, 176 (3), 159–164.

    OpenUrlCrossRefPubMedWeb of Science
25. 25.↵
    1. Clarke J. U.

    Evaluation of Censored Data Methods To Allow Statistical Comparisons among Very Small Samples with Below Detection Limit Observations. Environ. Sci. Technol. 1998, 32 (1), 177–183.

    OpenUrl
26. 26.↵
    1. Weenk G. H.

    Microbiological Assessment of Culture Media: Comparison and Statistical Evaluation of Methods. Int. J. Food Microbiol. 1992, 17 (2), 159–181.

    OpenUrlCrossRefPubMed
27. 27.↵
    1. Hayes R.

    Cost of Quality (CoQ)—An Analysis of the Cost of Maintaining a State of Compliance. Int. Pharm. Ind. 2014, 6 (1), 74–76.

    OpenUrl
28. 28.↵
    FDA Guidance for Industry. PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, U.S. Department of Health and Human Services: Silver Spring, MD, 2004.
29. 29.↵
    FDA Guidance for Industry. Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes, U.S. Department of Health and Human Services: Silver Spring, MD, 2010.
30. 30.↵
    PDA Technical Report 30. Parametric Release of Pharmaceutical and Medical Device Products Terminally Sterilized by Moist Heat. Parenteral Drug Association: Bethesda, MD, revised 2012.
31. 31.↵
    1. Tirumalai R.,
    2. Porter D.

    Terminal Sterilization and Potential for Parametric Release. Am. Pharm. Rev. 2005, 8 (4), 26–31.

    OpenUrl
32. 32.↵
    GMP Data Integrity Definitions and Guidance for Industry; Medicines and Healthcare Products Regulatory Agency, London, UK, 2016.
33. 33.↵
    FDA Data Integrity and Compliance with CGMP Guidance for Industry, Draft Guidance; U.S. Department of Health and Human Services: Silver Spring, MD, 2016.
34. 34.↵
    WHO Guidance on Good Data and Records Management Practices; World Health Organization: Geneva, Switzerland, 2015.
35. 35.↵
    Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments; PIC/S: Geneva, Switzerland, 2016.
36. 36.↵
    1. Sawant A.

    Lessons Learned in Microbial Data Integrity Management from a Manufacturer's Perspective. PDA Global Conference on Microbiology, Arlington, VA, 2016.
37. 37.↵
    1. Farquhar D. B.,
    2. Ho L.,
    3. Schwartz M. I.,
    4. The K.,
    5. Zucker J. B.

    International Pharmaceutical Supply Chain Imperiled Like Never Before. Webinar, 2016, September. https://www.dechert.com.